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Treatment Related CancerNCT04253249

Pancreatic Cyst Ablation With a Monopolar Radiofrequency Ablation Probe

An observational study of Treatment Related Cancer, run by Baylor College of Medicine at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Pancreatic cysts (A cyst is a thin walled cavity containing fluid) were rarely reported previously, but have been on a rise due to advanced imaging for evaluating pancreatic lesions or other medical reasons has increased detection of pancreatic cysts. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Treatment Related Cancer
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2018to 19 Dec 2020
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Groups to be recruited will include: Patients

Who may be able to join

  • -Adult (18-64 yrs), Geriatric (65+ yrs)

Who cannot join

  • Pregnant woman
  • Neonates
  • Children

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Endoscopic Ultrasound Guided Pancreatic Cyst Ablation With a Monopolar Radiofrequency Ablation Probe

Pancreatic cysts (A cyst is a thin walled cavity containing fluid) were rarely reported previously, but have been on a rise due to advanced imaging for evaluating pancreatic lesions or other medical reasons has increased detection of pancreatic cysts. Study shows transformation of pancreatic cysts to be 10.8 for every 100,000 women and 13.8 for every 100,000 men.

Pancreatic cysts are divided in two groups; serous and mucinous. Serous cysts are thin walled cysts and are not associated with precancer. On the other hand, mucinous cysts have a tendency to progress to pancreatic cancer.

Radio frequency ablation (RFA) is an alternative method used for patients who could not or decided to not undergo surgical removal of the cyst. This study is a standard of care study and no changes in regards to the procedure scheduled with the physician will be changed.

Read the detailed description

Pancreatic cysts were rarely reported previously, however, the increased use of advanced imaging techniques (mainly computerized topography and magnetic resonance imaging), for evaluating suspected pancreatic pathology or for other medical reasons has increased the detection of pancreatic cysts. Prevalence can range from 2.5-38% (1,3). These rates vary by patient's age and modality of imaging used (i.e: CT vs MRI). The rate of a malignant transformation in pancreatic cysts is not well known, however, very low. A study using the SEER data reported this rate to be 10.8 for every 100,000 women, or 13.8 for every 100,000 men with more than 85% of malignancies being detected in patient's age 40-84 years of age. (4) The most common histological type was adenocarcinoma, with mucinous producing tumors making about 4% of all adenocarcinomas detected. Pancreatic cysts are categorized under two major groups; serous and mucinous. Serous cystadenomas are thin walled cysts and are not associated with precancer. Mucinous cysts on the other hand have various diameters and contain viscous fluids which have the tendency to progress to pancreatic cancer. Radiofrequency ablation was recently proposed as an alternative for patients who could not or would not undergo surgical resection. In a recent study under the title "Endoscopic ultrasound guided radiofrequency ablation, for pancreatic cystic neoplasms and neuroendocrine tumors", eight patients with pancreatic cystic lesions were recruited for the study. Six patients had pancreatic cystic neoplasm. Post procedure imaging in 3-6 months showed complete resolutions of the cysts in 2 cases after using EUS RFA. No major complications were observed within 48 hours after the procedure, and two patients had mild abdominal pain which was resolved within 3 days after the surgery. (1) Management of pancreatic cysts includes surgical or non-surgical, or can be observational with repeat imaging. Management type depends on factors including pathologic features of the cyst on imaging (cyst size, enhancing cyst walls, duct size…etc), and the patient's ability to undergo surgery. Older patients with preexisting morbidities may not be eligible for a surgical resection, thus the use of endoscopic ultrasound interventions maybe appropriate. Endoscopic ultrasound guided radio frequency ablation has been used in treating certain pancreatic lesions, with a favorable pancreatic outcome (5)

Medical subject headings
Neoplasms, Second Primary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment pancreatic cyst without surgery

    Efficacy of managing pancreatic cyst without open surgery

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 May 2018
  3. Primary completion19 May 2020 (estimated)
  4. Study completion19 Dec 2020 (estimated)

Why it stopped: No funding was obtained.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04253249
Sponsor's protocol ID
H-38304
Status last verified
Jan 2020
First submitted
27 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Treatment Related Cancer, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment pancreatic cyst without surgery (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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